The Department-Related Parliamentary Standing Committee for the Ministry of Health and Family Welfare has sought the Centre to submit the response from the five states, including Maharashtra and Uttar Pradesh, among others, on the proposed project proposals for strengthening their state drug regulatory systems.

The Committee, in the latest report on the action taken by the Ministry on its recommendations from the previous report, said that it is of the considered view that vibrant, dynamic, strengthened drug testing laboratories are concomitantly efficient and effective drug regulatory mechanisms to avert the prevalence of sub-standard drugs.

"Therefore, the Ministry should instruct and guide the state governments to strengthen their state drug regulatory systems,” it said.

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“Moreover, the Committee wants to be informed of the response of the following states' governments to the Ministry’s perusal for submitting the project proposals matching the indicative amount of each state.":

- Maharashtra,
- Uttar Pradesh,
- Bihar,
- Tamil Nadu,
- Karnataka

"Understandably, the Ministry will continue to monitor optimal utilization of funds earmarked for the scheme,” it added.

In the previous report, the Committee took into account the lack of adequate drug control infrastructure and drug testing facilities across the States.

“The Committee strongly believes that for the development of a vibrant drug manufacturing industry, issues related to the supply of poor quality drugs need to be resolved."

"It is an established fact that Strengthening of state drug regulatory system is the keystone for addressing the issues of substandard drugs,” it said in the previous report.

It also noted the plea of the Ministry that the lack of proposals from states for strengthening state drug regulatory systems has been one of the primary reasons for underutilization under the Scheme.

The nonsubmission of proposals from states especially, States with a higher allocation of the indicative amount, is not tenable.

It is then recommended that states, especially Maharashtra, Uttar Pradesh, Bihar, Tamil Nadu, and Karnataka, may be persuaded to submit project proposals matching the indicative amount.

The Ministry may also follow up with all the states and make efforts to set up a sufficient number of laboratories The Committee emphasized the need for cooperation between the States and the Union government to establish a vibrant, dynamic, and effective drug regulatory regime.

In response to this previous report, the Ministry responded that it has been making concerted efforts to implement the Scheme of Strengthening of the State Drug Regulatory System with all the states/UTs for signing the Memorandum of Understanding under the scheme and submitting project proposals for release of grant-in-aid.

All the states/UTs which have received Grants-in-Aid have also been requested to furnish Utilization Certificates (USs) and detailed progress reports of the projects undertaken through a number of virtual meetings and repeated communications.

Up to March 31, 2022, a Grant-in-Aid of Rs. 642.18 crores has been released to the states/UTs. This scheme has paved the way for the setting up of 17 new drug testing labs and the renovation/upgradation of 26 existing ones, as well as the setting up of 48 new offices for drug controllers and the upgradation of 27 existing similar offices.

In line with the recommendations of the Committee, the states of Maharashtra, Uttar Pradesh, Bihar, Tamil Nadu, and Karnataka are being persuaded to submit the project proposals matching their indicative amount, said the Ministry. Further, all the other states/UTs are also being requested to set up a sufficient number of drug testing laboratories to meet their requirements, it added.

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